17 - 18 Februar 2020 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes. Practical…
5 - 6 March 2020 in Frankfurt, Germany - Regulatory requirements for package inserts and packaging, artwork management, GMP-compliant documentation and quality control, IDMP, SPOR, XEVMPD - maintain product information online, labelling in the focus of audits and inspections
Regulatory requirements for package inserts and packaging, artwork management
24 - 25 September 2020 in Heidelberg, Germany - Regulatory requirements for package inserts and packaging, artwork management, GMP-compliant documentation and quality control, IDMP, SPOR, XEVMPD - maintain product information online, labelling in the focus of audits and inspections
3 December 2019 in Berlin, Germany - Completing this seminar deems you legaly fit to prepare SmPCs, package inserts and in the labelling of the packaging. You learn the scopes and limits of preparation and receive solution options.
27 - 28 November 2019 in Bonn, Germany - Patient‘s expectations, Patient compliant packaging, Regulatory aspects, PI and medication errors, Electronic leaflets and mobile technologies
24 - 25 June 2019, Mannheim, Germany - This seminar delivers profound know-how of the labelling process chain from preparation of the package insert, the artwork and the packaging up to GMP-relevant aspects. Afterwards, you are up-to-date with regulatory requirements.
9 - 10 April 2019 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: free writing versus regulatory restrictions; editing and proofreading documents; package leaflet - regulatory linguistic restrictions and user-friendly writing.
The use of colour to emphasise important information and headings of package leaflets has been recommended in the EU readability guideline since 1998. Our study investigated the advantages and disadvantages of coloured and black/greyscale versions. The results show that both options are appropriate for package leaflets.
Read more28 June 2018 in Cologne, Germany, and 4 December 2018 in Berlin, Germany - Product information: SmPC, package insert and labelling
Using German package leaflets over the period from 2005 to 2015 as example, the study results show significant improvements, such as the increase in font sizes, line spacing and the more frequent use of highlighting. However, a significant increase in the volume of text has been found.
Read more28 - 29 June in Berlin, Germany, 7 - 8 December 2017 in Cologne, Germany - Product information, including workshop to prepare SmPC, package insert and labelling
26 January 2017, Cologne, Germany - QRD template implementation, company-internal adjustments, practical exercises
The results in the written readability test with 234 participants do not show an advantage of the landscape format over the portrait format. This finding negates the EU readability guideline’s stated preference for the landscape format.
Our analysis over 3 years of all English-language package leaflets available on the EMA website showed a significant text increase in package leaflets, whereby one mean reason is the huge text increase of the QRD template.
Read more Read moreResource-saving solutions that additionally guarantee a good standard of legibility for package leaflets, such as text compression and targeted paper selection, can be found in the following.
Dr. Anna Wolf finalised her extensive work in February 2015 concerning the QRD template of the European Union, under PAINT-Consult’s supervision at the University of Bonn.
Read moreThe results of two investigations of 258 randomly selected German package leaflets show that opacity is a more appropriate tool for assessing paper quality than the paper weight recommended in the readability guideline.
Since QRD template version 9.1 this list is no longer essential.
Read more26 - 27 February 2015, Bonn, Germany - Workshop: experience with readability user testing, using QRD templates
10 - 12 February 2014, Bonn , Germany - Workshop: use of QRD templates, questions relating to labeling
Address: Wenigenjenaer Ufer 12, 07749 Jena, Germany
17 - 18 January 2013, London, United Kingdom - Presentation: Learning from current experience - did readability tests improve the quality of information and satisfy patients' needs?
The Forsa Opinion Research Institute, acting on behalf of the ERGO Insurance Group AG, interviewed 2600 people. The results show that package inserts are the most comprehensible product information in Germany.
14 February 2012, Berlin, Germany - Presentation: The new QRD templates for product information
6 April 2011, London, UK - Presentation: The "ideal" OTC package insert
14 February 2011, Berlin, Germany - Presentation: Readability Guideline and Labelling: Current experience on implementation and readability tests.
CMDh once again recommended PAINT-Consult's written readability test method as an alternative
Read more26 November - 3 December 2010, University of Bonn, Germany - Presentation: Patient information via package inserts within the European Union
Supervised by PAINT-Consult, Dr. Claudia Hertzsch completed her dissertation relating to: Possibilities and limitations in preparing patient-friendlier package inserts with regard to content, formal design and amount of text.
PAINT-Consult completes the PAINT3 study - a readability test study of 271 randomly selected German package inserts with 5091 participants.
In the readability guideline (PDF) the European Commission stipulated a minimum font size of 9pt as recommended by PAINT-Consult, instead of the originally intended 12 to 20pt (PDF). This is based on the font size study of PAINT-Consult published in May 2008 (PDF).
5 December 2008, London, United Kingdom - Presentation: The way forward on user testing - CRO's perspective
PAINT2 study is accomplished. This is an analysis of 271 package inserts randomly chosen from those available on the German medicine market in 2005.
Scientific leadership of the large vaccination advice campaign for pharmacies in Mecklenburg-Western Pomerania (Germany) during 2007, including training courses for pharmacy staff
Scientific leadership of the large vaccination advice campaign for pharmacies in Brandenburg (Germany) during 2007, including training courses for pharmacy staff
Scientific leadership of the large vaccination advice campaign in pharmacies throughout Thuringia (Germany) during 2005, including training courses for pharmacy staff
Dissertation, 2015
Last update: 13.04.2021
